Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60-74
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

About this trial

Phase III, open label, randomised, multicentre, blind for evaluators clinical trial to evaluate the efficacy of esketamine nasal spray at flexible dosis compared to aripiprazole in elderly participants (\>60 years) who suffer from treatment-resistant major depressive

Eligibility criteria

Qualifiers

Patients between 60-74 years

To be receiving antidepressant treatment that includes an antidepressant at the time of screening that is not responding (less than 25% improvement in symptoms) after receiving an adequate dose [or local equivalent, if applicable] for at least 6 weeks and have been increased to the dose maximum allowed

Current antidepressant treatment must have been immediately preceded by failure to respond to at least 3, but not more than 5, different consecutive treatments (all within the same moderately severe depressive episode) with antidepressant drugs (AD) taken at an appropriate dose for at least least 6 weeks (3 antidepressant failures including the current one)

To have been treated with at least 3 different classes of antidepressants between treatments taken at appropriate doses for at least 6 weeks without response in the current moderate to severe depressive episode (including current treatment with an antidepressant)

Disqualifiers

Treatment with drugs contraindicated with the use of esketamine and aripiprazole.

Patients in whom a high risk of suicide is detected at the screening visit, according to the criteria established by Columbia University according to the C-SSRS evaluation

Patients who are participating in another clinical trial with active treatment

Patients who do not have the capacity to consent to participation in the trial or who do not have a representative to confirm their participation

Trial design

Treatments tested in this trial

  • Experimental regimen
  • Control regimen

Treatment groups

220 Participants
are divided into 2 treatment groups